Senior Associate Device Engineer - Grade 6 in Cambridge

• Duration: 12 Months
• Overview

Tek Wissen is a global workforce management provider throughout the UK, Europe and many other countries in the world.

The below client is an American multinational pharmaceutical and biotechnology corporation.

Job Description

• To provide technical project support within the Device Engineering Sciences team through the testing, analysis, and evaluation of novel drug delivery devices, components, and primary containers (e. g. syringes and cartridges).
• The role is responsible for risk assessment and mitigation, including execution and analysis of experimental work in accordance with established SOPs and quality standards.
• The individual will act as a Subject Matter Expert in device development, applying their knowledge of specification setting, problem solving, engineering assessment, analytical method development, and design verification to support robust, compliant, and data-driven device development activities.
• Important qualities include the ability to work accurately and within agreed deadlines and in compliance with established working practices.
• Major Duties
• Work as part of a multidisciplinary team to determine what performance factors of the drug delivery device will require assessment and investigation.
• Support Design Engineering Science project lead with authoring, review, and management of design control documentation.
• Support interactions with external vendors and internal partners within the following activities: design assessment, design verification, and manufacturing process qualification for drug delivery devices.
• Support design and development of test methods, experimental rigs and test setups
• Support early-stage usability and market research studies to identify user requirements
• Design test rigs and challenge parts
• Assess supplier designs and strategies to identify critical to function areas, likely failure modes and design sensitivities
• Risk management assessment and mitigation, including input to d FMEA and u FMEA
• Application of statistical, scientific and engineering expertise and research experience to solve problems creatively and independently and support decision making.
• Use of analytical and statistical tools to analyse the data in order to quantify the functional performance characteristics of the device, the controlling parameters for its consistent performance, etc.
• Define appropriate approaches to quantify design parameters, including design of experiments and statistical interpretation of data.
• Operate laboratory equipment according to SOPs, Manuals, Methods and Risk assessments etc.
• Responsible for a wide variety of ISO 13485 related documentation and laboratory tasks including change control, instrument managing instrument compliance, inventory control and trouble‑shooting as needed.
• Responsible for data management including transcription, verification, and analysis of testing results.
• Prepare scientific reports of experiment, data analysis and data verification in accordance with approved procedures and practices.
• Perform other duties as assigned in support of business goals.

Person Specification

Education

• Degree, HND or equivalent in relevant Science or Engineering subject.
• Evidence of sustained level of achievement.
• Good theoretical knowledge and understanding of academic subjects.

Experience

• Previous experience of working with device control system life cycle and device testing.
• Good knowledge of mechanical and/or electronic testing of drug delivery device
• Experience of working in teams in the development or trouble shooting of drug delivery devices, analytical methodology or manufacturing processes by means of designed experiments and logical problem solving.
• Working experience of test method development and validation
• Demonstrates a knowledge and background in design assessment, specification setting, analytical method development, and design verification (including stability & transportation) for drug delivery devices.

Tek Wissen® Group is an equal opportunity employer supporting workforce diversity.

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